The Therapeutic Goods Administration has backed wider access to lamb and calf pain relief products lidocaine and oral transmucosal meloxicam, rejecting appeal arguments from the Australian Veterinary Association.
However, the AVA intends to continue its fight to make the formulations – marketed as NumOcaine and Ilium Buccalgesic OTM respectively by Troy Laboratories – for use only under veterinary prescription.
NumOcaine is administered from a tamper evident vial as an injectable lidocaine as part of the Numnuts system for pain relief when branding lambs and calves. Buccalgesic is a meloxicam gel administered orally into the buccal (cheek) pouch in lambs.
In September last year, the Therapeutic Goods Administration deferred lidocaine (NumOcaine) from an S4 prescription-only veterinary drug to S5 on the standard Poisons, allowing it to be sold through rural dealers. Buccalgeisc has also been postponed.
The AVA then appealed the TGA’s postponement, citing concerns about potential misuse, toxicity, and the degree of tamper resistance offered by the NumOcaine cartridge.
However, last Friday the TGA released its delegate’s decision, which concluded that the benefits of increased access to an injectable preparation of lidocaine outweigh the potential risks.
“Therefore, I have decided not to change the Poisons standard with respect to lidocaine.”
TGA decision ‘a blow of total relief’
Numnuts founder Robin Smith said that in the three years of Numnuts being on the market, the company has received many calls from farmers and local councils to streamline availability and access to our painkiller product.
“The rescheduling process began over two years ago, and with the support of hundreds of farmers, the RSPCA, WoolProducers, Sheep Producers of Australia and Australian Wool Innovation and vets representing the industry , NumOcaine was successfully reprogrammed to S5 status in July 2022, paving the way for greater access.
“The attempt to reverse this decision by AVA policymakers has remained like a rubber ring on a core part of the anatomy of our businesses for over nine months now.
“The decision made by the TGA today feels like a complete relief,” he said.
“This third green light from TGA allows us to plan for the future.
“We remain committed to working with veterinarians to increase adoption and ensure the best animal welfare outcomes,” Smith said.
“By working with all players in the agricultural supply chain, we hope to see an increase in the use of Numnuts/NumOcaine.
“Achieving this goal will allow us to fund more R&D on improved formulations and hopefully a pain relief solution for ring castration of the young calf,” Smith said.
“In the future, we hope to find a way for everyone involved in animal welfare; farmers, veterinarians, scientists, rural marketers and innovators, to achieve a sustainable business model that works for everyone.
Although NumOcaine in June this year was approved by the Australian Pesticides and Veterinary Medicines Authority for over-the-counter sales, it will only be available to vets this year due to current labeling laws. Mr Smith said NumOcaine labeled for over-the-counter sale will not be available until 2023.
Sheep vets to appeal TGA interim decisions
The President of Sheep, Camelid and Goat Veterinarians (an AVA Special Interest Group), Dr. Susan Swaney, said the SCGV is extremely disappointed with the TGA’s interim decision to authorize lidocaine (NumOcaine) to remain an S6 and for deferral of Meloxicam 1 percent to S6.
“A decision to make these products available to sheep producers on the open market will limit the ability of veterinarians to help producers make the best available drug choices to reduce pain during routine animal husbandry procedures on the sheep,” she said.
Dr Swaney said SCGV concerns include the potential for lidocaine (NumOcaine) toxicity, particularly when used with Trisolfen during mulesing, the limited duration of activity of NumOcaine and the development of a posterior paresis in lambs where the needle is inserted incorrectly.
“Despite the fact that most farmers want to do the right thing for their livestock, there is still a portion of farmers and also other members of the public who will now have access to unlimited volumes of these products, which can choosing to use them in the wrong direction.
“Unfortunately, as a veterinarian, I have seen many occasions where animals have been seriously abused because people thought they could perform procedures without the proper training,” she said.
“I believe that completely unrestricted access to these drugs will greatly increase the possibilities for this type of abuse with disastrous results not only for sheep, but for several animal species and potentially for humans.”
Dr Swaney said the welfare of all animals is a top concern for veterinarians.
“As such, it is our obligation to continue to appeal this interim decision in the hope that the best outcome can be found for sheep and goat producers and their flocks as well as any other animals or humans who may be affected by this decision.”
Dr Swaney said she hoped sheep farmers who had given it careful thought would realize that a decision to change access to these products could lead to an increased potential for misuse, particularly when anyone who could potentially buy as much as they wanted online.
“Advice from veterinarians, including how to use them, alone or in combination, for immediate and long-term pain relief and to avoid potential side effects or toxicity, will help producers make the most effective choices. practical and profitable for their livestock.
“Consumers are becoming more aware of how their food is produced and I think they expect there to be some veterinary oversight of animal welfare on farms,” a- she declared.
“SCG veterinarians work hard to connect with their customers and this relationship is crucial to ensuring the industry is well protected and well resourced in the future.”
Lidocaine abuse potential is minimal – TGA
The TGA delegate said that injectable lidocaine preparations for animal use have a favorable safety profile with low potential for harm to humans and that a product considered to have tamper evident packaging by the regulator also has a reduced risk of diversion and misuse. Using the applicator also reduces the likelihood of accidental self-injection when administering lidocaine to the animal, the delegate said.
The delegate also stated that the abuse potential of lidocaine is minimal to non-existent, as the substance is not addictive and is not considered a drug of abuse. The isolated reports provided in the appeal request are insufficient to demonstrate that misuse of an injectable preparation of lidocaine intended for veterinary use is likely. Given that lidocaine is currently readily available at relatively low cost in a multitude of different preparations for human use, the delegate considered it unlikely that veterinary preparations of this type would be diverted in this manner. I also consider it unlikely that these lidocaine preparations will be used to dilute or “cut” illicit drugs, the delegate said.
“Based on the number of public submissions indicating difficulties in accessing lidocaine for veterinary procedures, I disagree with the Applicant’s statement that there are no significant barriers to access.
“Allowing greater access to lidocaine with the appropriate safeguards in place, as provided by the specialized packaging (applicator) should contribute to greater use of analgesics by the agricultural community for these veterinary procedures, particularly in remote areas where veterinary supervision may not be readily available.
“In making my decision, I agree with the committee (TGA Drugs and Chemicals Planning Advisory Committee) that there is insufficient evidence of actual or potential adverse effects associated with lidocaine preparations that would be captured by the existing Schedule 5 entry, to justify cancellation the original decision was to introduce a specific entry for the specified indications and applicator.
Click here to read the full TGA decisions.